TxTi IBF System
K-Number: K183064 · 2019-06-28
ApplicantInnovasis, Inc.
Decision Date2019-06-28
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TxTi IBF System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2019-06-28 under approval number K183064. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TxTi IBF System?
TxTi IBF System is a medical device that received FDA 510(k) clearance on 2019-06-28. It is manufactured by Innovasis, Inc.. The 510(k) number is K183064.
When was TxTi IBF System approved by the FDA?
TxTi IBF System received FDA 510(k) clearance on 2019-06-28, under approval number K183064.
What company makes TxTi IBF System?
TxTi IBF System is manufactured by Innovasis, Inc..
What is the FDA product code for TxTi IBF System?
The FDA product code for TxTi IBF System is MAX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.